prescribing information - baxter

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PRESCRIBING INFORMATION

20% Dextrose Injection, USP


70% Dextrose Injection, USP In Single Dose Partial Filled Containers

IV Fluid and Nutrient Replenisher

Baxter Corporation

Mississauga, Ontario L5N 0C2

Canada

Date of Revision:

November 21, 2018

Submission Control No: 220929

Baxter and Viaflex are trademarks of Baxter International Inc.

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20% Dextrose Injection, USP/

50% Dextrose Injection, USP/


NOT FOR DIRECT INFUSION BEFORE COMPOUNDING/DILUTION

In Single Dose Partial Filled Containers

SUMMARY PRODUCT INFORMATION

20% Dextrose Injection, USP, 50% Dextrose Injection, USP and 70% Dextrose Injection, USP

are sterile, nonpyrogenic, hypertonic solutions for fluid replenishment and caloric supply in

single dose containers for intravenous administration after compounding. They contain no

antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1.

Table 1. Product Information.

***

DEX

USP

g/L

OSMOLARITY

(mOsmol/L)

*kcal/L **kJ/L pH CODE VOLUME

20%

DEXTROSE INJ

USP

200 1010 680 2842.4 4.0 JB0124 500/1400

mL

50%

DEXTROSE INJ

USP

500 2523 1700 7106 4.0 JB0264 500/1400

mL

70%

DEXTROSE INJ

USP

700 3530 2380 9948.4 4.0 JB0114 500/1400

mL

* Dex = 3.4 kcal/g

** 1 kcal = 4.18 kJ

*** the dextrose is purified from corn and may contain fructose.

The structural formula of Dextrose Hydrous, USP is:

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The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL

146 Plastic) with di-2-ethylhexyl phthalate (DEHP) as a plasticizer. Exposure to temperatures

above 25˚C during transport and storage will lead to minor losses in moisture content. Higher

temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically

significant changes within the expiration period. The amount of water that can permeate from

inside the container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the plastic container can leach out certain of its chemical components

in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to

5 parts per million. No safety issues of the plastic material were identified in USP biological tests

in animals as well as by tissue culture toxicity studies.

ACTIONS

The Dextrose Injections, USP products have value as a source of water and calories. They are

capable of inducing diuresis depending on the clinical condition of the patient.

INDICATIONS AND CLINICAL USE

20% Dextrose Injection, USP, 50% Dextrose Injection, USP and 70% Dextrose Injection, USP

products are indicated as a caloric component in a parenteral nutrition regimen in clinical

conditions where enteral nutritional support is or is expected to be insufficient or impossible.

These products are used with an appropriate amino acid (nitrogen) source in the prevention of

nitrogen loss or in the treatment of negative nitrogen balance in patients.

CONTRAINDICATIONS

20% Dextrose Injection, 50% Dextrose Injection, USP and 70% Dextrose Injection, USP

products are contraindicated in the following conditions:

• Patients with hypersensitivity to any ingredient in the formulation or component of the

container. For more information, see DESCRIPTION section;

• Patients with known allergy to corn or corn products since dextrose in the product is

purified from corn.

• Patients having intracranial or intraspinal hemorrhage;

• Patients who are severely dehydrated;

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• Patients who are anuric, and in patients in hepatic coma;

• Patients with clinically significant hyperglycemia.

WARNINGS AND PRECAUTIONS

General

These products should not be directly infused before appropriate dilution due to their high level

of osmolarity (see Table 1). When diluted with an amino acid (nitrogen) source, the resultant

solution should have an appropriate calorie to gram of nitrogen ratio and an osmolarity consistent

with the route of administration.

Infusion of hypertonic dextrose injection into a peripheral vein may result in vein irritation, vein

damage, and thrombosis. Strongly hypertonic nutrient solutions should only be administered

through an indwelling intravenous catheter with the tip located in a large central vein such as the

superior vena cava.

In very low birth weight infants, excessive or rapid administration of dextrose injection may

result in increased serum osmolality and possible intracerebral hemorrhage.

WARNING: These products contain aluminum which may be toxic. Aluminum may reach toxic

levels with prolonged parenteral administration if kidney function is impaired. Premature

neonates are particularly at risk because their kidneys are immature, and they require large

amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates,

who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate

aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may

occur at even lower rates of administration.

These products contain no more than 25 mcg/L of aluminum.

Administration by central venous catheter should be used only by those familiar with this

technique and its complications.

To reduce the risk of HYPOglycemia after discontinuation, a gradual decrease in flow rate

before stopping the infusion should be considered.

These products may contain fructose. Exercise caution when they are used in patients with

hereditary fructose intolerance due to aldolase deficiency. In these patients, fructose may result

in hypoglycemia, metabolic acidosis, liver toxicity which manifests as vomiting, nausea,

sweating, jaundice, hemorrhage, seizures or coma or even death. The severity of the reactions is

dependent on the amount and duration of fructose intake.

Hypersensitivity Reactions

Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, have been

reported with Dextrose Injection, USP (see Adverse Reactions).

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The infusion must be stopped immediately if any signs or symptoms of a suspected

hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as

clinically indicated.

Dilution and other effects on serum electrolytes

Depending on the volume and rate of infusion and depending on a patient’s underlying clinical

condition and capability to metabolize dextrose, intravenous administration of dextrose can

cause:

• Hyperosmolality, osmotic diuresis and dehydration

• Hypoosmolality

• Electrolyte disturbances such as

• Hypo- or Hyperosmotic Hyponatremia,

• Hypokalemia,

• Hypophosphatemia,

• Hypomagnesemia,

• overhydration/Hypervolemia and, for example, congested states, including pulmonary

congestion and edema.

Hypoosmotic hyponatremia

Acute hyponatremia can lead to acute hyponatremic encephalopathy (brain edema) characterized

by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular

risk of severe, irreversible and life-threatening brain injury.

The risk for developing hypoosmotic hyponatremia is increased, for example,

• in children

• in elderly patients

• in women

• postoperatively

• in persons with psychogenic polydipsia

The risk for developing encephalopathy as a complication of hypoosmotic hyponatremia is

increased, for example,

• in pediatric patients (≤16 years of age)

• in women (in particular, premenopausal women)

• in patients with hypoxemia

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• in patients with underlying central nervous system disease.

Particular caution is advised in patients at increased risk of and from water and electrolyte

disturbances that could be aggravated by increased free water load, HYPERglycemia or possibly

required insulin administration (see below).

Preventive and corrective measures must be instituted as clinically indicated.

HYPERglycemia

As with the intravenous administration of nutrients (e.g., glucose, amino acids and lipids) in

general, metabolic complications may occur if the nutrient intake is not adapted to the patient’s

requirements, or the metabolic capacity of any given dietary component is not accurately

assessed. Adverse metabolic effects may arise from administration of inadequate or excessive

nutrients or from inappropriate composition of an admixture for a particular patient’s needs.

Rapid administration of dextrose-containing solutions may produce substantial hyperglycemia

which may result in or contribute to electrolyte losses, dehydration and hypovolemia due to

osmotic diuresis and a hyperosmolar syndrome. At certain clinical conditions it also may

increase the risk of hypoosmotic hyponatremia by shifting of intracellular water to extracellular

space, result in serious clinical outcomes (see text under the subheading "Hypoosmotic

hyponatremia" in this section).

Use with caution in critically ill patients in whom hyperglycemia commonly occurs due to

diabetes, impaired glucose tolerance, impaired fasting glucose, or is stress-induced

Hyperglycemia may increase the risk of cardiac complications, infection, systemic sepsis, acute

renal failure and even death in certain clinical conditions, especially in acute stress conditions.

In order to avoid HYPERglycemia the infusion rate should not exceed the patient’s ability to

utilize glucose.

To reduce the risk of HYPERglycemia-associated complications, the infusion rate must be

adjusted to the level suitable to the patient’s ability to utilize glucose and/or insulin administered

if blood glucose levels exceed levels considered acceptable for the individual patient.

Intravenous dextrose should be administered with caution in patients with, for example:

• impaired glucose tolerance (such as in diabetes mellitus, renal impairment, or in the

presence of sepsis, trauma, or shock),

• severe malnutrition (risk of precipitating a refeeding syndrome),

• thiamine deficiency, e.g., in patients with chronic alcoholism (risk of severe lactic

acidosis due to impaired oxidative metabolization of pyruvate),

• water and electrolyte disturbances that could be aggravated by increased glucose and/or

free water load (see above)

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• patients with ischemic stroke. HYPERglycemia has been implicated in increasing

cerebral ischemic brain damage and impairing recovery after acute ischemic strokes.

• patients with severe traumatic brain injury (in particular during the first 24 hours

following the trauma). Early HYPERglycemia has been associated with poor outcomes in

patients with severe traumatic brain injury.

• Newborns (see Use in Pediatric Patients).

Prolonged intravenous administration of dextrose and associated HYPERglycemia may result in

decreased rates of glucose-stimulated insulin secretion.

Refeeding Syndrome

Refeeding severely undernourished patients may result in the refeeding syndrome that is

characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient

becomes anabolic. Thiamine deficiency and fluid retention may also develop. Careful monitoring

and slowly increasing nutrient intakes while avoiding overfeeding can prevent these

complications.

Liver Disorders

Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly

leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in

some patients on parenteral nutrition. The etiology of these disorders is thought to be

multifactorial and may differ between patients. Patients developing abnormal laboratory

parameters or other signs of hepatobiliary disorders should be assessed early by a clinician

knowledgeable in liver diseases in order to identify possible causative and contributory factors,

and possible therapeutic and prophylactic interventions.

Catheter infection and sepsis

Infection and sepsis may occur as a result of the use of intravenous catheters to administer

parenteral formulations, poor maintenance of catheters or contaminated solutions.

Immunosuppression and other factors such as HYPERglycemia, malnutrition and/or their

underlying disease state may predispose patients to infectious complications.

Careful symptomatic and laboratory monitoring for fever/chills, leukocytosis, technical

complications with the access device, and HYPERglycemia can help recognize early infections.

The occurrence of septic complications can be decreased with heightened emphasis on aseptic

technique in catheter placement, maintenance, as well as aseptic technique in nutritional formula

preparation.

Precipitates

Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In

some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate

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increases the risk of the formation of calcium phosphate precipitates. Precipitates have been

reported even in the absence of phosphate salt in the solution. Precipitation distal to the in‐line

filter and suspected precipitate formation in the blood stream has also been reported.

In addition to inspection of the solution, the infusion set and catheter should also periodically be

checked for precipitates.

If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation

initiated.

Administration of hypertonic dextrose and amino acid solutions via central venous catheter may

be associated with complications which can be prevented or minimized by careful attention to all

aspects of the procedure. This includes attention to solution preparation, administration and

patient monitoring.

It is essential that a carefully prepared protocol, based upon current medical practice, be

followed, preferably by an experienced team.

The package insert of the protein (nitrogen) source should be consulted for dosage and all

precautionary information.

Care should be taken to avoid circulatory overload, particularly in patients with cardiac

insufficiency.

These injections should be used with caution in patients with overt or subclinical diabetes

mellitus.

Dextrose Injection, USP (an aqueous, i.e., electrolyte-free dextrose solution) should not be

administered simultaneously with blood through the same administration set because of the

possibility of pseudoagglutination or hemolysis.

Risk of Air Embolism

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible

residual air contained in the primary container.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates

can result in air embolism if the residual air in the container is not fully evacuated prior to

administration.

Use of a vented intravenous administration set with the vent in the open position could result in

air embolism. Vented intravenous administration sets with the vent in the open position should

not be used with flexible plastic containers.

Monitoring and Laboratory Tests

Clinical evaluation and periodic laboratory determination are necessary to monitor changes in

plasma glucose level, fluid balance, electrolyte concentrations, and acid-base balance during

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prolonged parenteral therapy or whenever the condition of the patient or the rate of

administration warrants such evaluation.

Monitoring of serum sodium is particularly important. High volume infusion must be used under

specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-

osmotic vasopressin release (including Syndrome of Inappropriate Antidiuretic Hormone

Secretion (SIADH)), due to the risk of hospital-acquired hyponatremia.

Carcinogenesis and Mutagenesis

Studies with Dextrose Injection, USP have not been performed to evaluate carcinogenic

potential, mutagenic potential, or effects on fertility.

Special Populations

Pregnancy and Lactation

Animal reproduction studies have not been conducted with Dextrose Injection, USP. It is also not

known whether Dextrose Injection, USP can cause fetal harm when administered to a pregnant

woman or can affect reproduction capacity. Dextrose Injection, USP should be given to a

pregnant woman only if clearly needed.

Nursing Mothers: Caution should be exercised when Dextrose Injection, USP is administered to

a nursing woman.

Intrapartum maternal intravenous dextrose infusion may result in fetal insulin production, with

an associated risk of fetal HYPERglycemia and metabolic acidosis as well as rebound

HYPOglycemia in the neonate.

Healthcare practitioners should carefully consider the potential risks and benefits for each

specific patient before administering.

Pediatrics

Due to hypertonicity, these dextrose injections must be diluted prior to administration.

The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of

the patient, concomitant therapy and should be determined by the consulting physician

experienced in pediatric intravenous fluid therapy.

Pediatric Glycemia-related Issues

Newborns – especially those born premature and with low birth weight, are at increased risk of

developing HYPO- or HYPERglycemia. Close monitoring during treatment with intravenous

dextrose solutions is needed to ensure adequate glycaemic control, in order to avoid potential

long term adverse effects.

HYPOglycemia in the newborn can cause:

• prolonged seizures,

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• coma, and

• cerebral injury.

HYPERglycemia has been associated with

• cerebral injury, including intraventricular hemorrhage,

• late onset bacterial and fungal infection,

• retinopathy of prematurity,

• necrotizing enterocolitis,

• bronchopulmonary dysplasia

• increased oxygen requirements,

• prolonged length of hospital stay, and

• death.

Pediatric Hyponatremia-related Issues

Children (including neonates and older children) are at increased risk of developing hypoosmotic

hyponatremia as well as for developing hyponatremic encephalopathy.

Acute hyponatremia can lead to acute hyponatremic encephalopathy (brain edema) characterized

by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular

risk of severe, irreversible and life-threatening brain injury.

Plasma electrolyte concentrations should be closely monitored in the pediatric population.

Rapid correction of hypoosmotic hyponatremia is potentially dangerous (risk of serious

neurologic complications). Dosage, rate, and duration of administration should be determined by

a physician experienced in pediatric intravenous fluid therapy.

Geriatrics

When selecting the type of infusion solution and the volume/rate of infusion for a geriatric

patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic,

and other diseases or concomitant drug therapy.

ADVERSE REACTIONS

Too rapid infusion of a hypertonic dextrose solution may result in diuresis, HYPERglycemia,

glycosuria and hyperosmolar coma. Continual clinical monitoring of the patient is necessary in

order to identify and initiate measures for these clinical conditions.

Reactions which may occur because of the solution or the technique of administration include

febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from

the site of injection, extravasation and hypervolemia.

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Anaphylactic reaction, hypersensitivity, pyrexia, and chills have also been reported.

The list of adverse reactions in this Prescribing Information is based on postmarketing reports

(see below).

If an adverse reaction does occur discontinue the infusion, evaluate the patient, institute

appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if

deemed necessary.

Post-marketing Adverse Reactions

The following adverse reactions have been reported in the post-marketing experience, listed by

MedDRA System Organ Class (SOC), then, where feasible, by Preferred Term in order of

severity.

IMMUNE SYSTEM DISORDERS: Hypersensitivity/infusion reactions, including

Anaphylactic/Anaphylactoid reactions, including reactions with mild manifestations, e.g.,

Pruritus, and reactions with severe manifestations, e.g., Bronchospasm, Cyanosis, Angioedema

and Hypotension; Pyrexia, Chills

METABOLISM AND NUTRITION DISORDERS: HYPERglycemia

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Rash

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Infusion site

reactions including, Infusion site phlebitis, Infusion site erythema.

Other adverse reactions reported with dextrose injection/infusions include:

• Hyponatremia, which may be symptomatic (see under the subheading “Hypoosmotic

hyponatremia” in WARNINGS AND PRECAUTIONS).

• Hyponatremic encephalopathy

• Infusion site thrombophlebitis (associated with hyperosmolar solutions).

• Adverse reactions reported with parenteral nutrition to which the dextrose component

may play a causal or contributory role include:

o Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic

steatosis, Blood bilirubin increased, Hepatic enzyme increased, Cholecystitis,

Cholelithiasis

o Pulmonary vascular precipitates

DRUG INTERACTIONS

No studies have been conducted by Baxter Healthcare Corporation.

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Caution must be exercised in the administration of these injections to patients receiving

corticosteroids or corticotropin.

Both the glycemic effects of Dextrose Injection, USP and its effects on water and electrolyte

balance should be taken into account when using Dextrose Injection, USP in patients treated with

other substances that affect glycemic control, or fluid and/or electrolyte balance.

Caution is advised when administering Dextrose Injection, USP to patients treated with drugs

leading to an increased vasopressin effect. The below listed drugs increase the vasopressin

effect, leading to reduced renal electrolyte free water excretion and may increase the risk of

hyponatremia following treatment with i.v. fluids.

• Drugs stimulating vasopressin release such as chlorpropamide, clofibrate,

carbamazepine, vincristine, selective serotonin reuptake inhibitors (SSRIs), 3.4-

methylenedioxy-N-methamphetamine, ifosfamide, antipsycotics, opioids.

• Drugs potentiating vasopressin action such as chlorpropamide, non steroidal anti-

inflammatories (NSAIDS), cyclophosphamide.

• Vasopressin analogues such as desmopressin, oxytocin, vasopressin, terlipressin.

Caution is advised when administering Dextrose Injection, USP to patients treated with drugs

that may increase the risk of hyponatremia, such as diuretics and antiepileptics (e.g.,

oxcarbazepine).

DOSAGE AND ADMINISTRATION

The dextrose injection products have high osmolarity (see Table 1).

Administration of HYPERosmolar solutions may cause phlebitic complications, such as vein

irritation, vein damage, and thrombosis.

The osmolarity of a final admixed infusion solution must be taken into account when peripheral

administration is considered.

Following suitable admixture of prescribed drugs, the dosage is usually dependent upon the age,

weight and clinical condition of the patient as well as laboratory determinations. See directions

accompanying drugs.

As reported in the literature, the dosage selection and constant infusion rate of intravenous

dextrose must be selected with caution in pediatric patients, particularly neonates and low birth

weight infants, because of the increased risk of HYPERglycemia / HYPOglycemia. Frequent

monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric

patients, particularly neonates and low birth weight infants. The infusion rate and volume

depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy

and should be determined by the consulting physician experienced in pediatric intravenous fluid

therapy.

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A gradual increase of flow rate should be considered when starting administration of dextrose-

containing products.

Electrolyte supplementation may be indicated according to the clinical needs of the patient.

As indicated on an individual basis, vitamins and trace elements and other components

(including amino acids and lipids) can be added to the parenteral regimen to meet nutrient needs

and prevent deficiencies and complications from developing.

Additives may be incompatible. Complete information is not available. When introducing

additives to Dextrose Injection, USP, the instructions for use of the medication to be added and

other relevant literature must be consulted.

Those additives known to be incompatible with these products should not be used. Consult with

pharmacist if available. If in the informed judgment of the physician it is deemed advisable to

introduce additives, aseptic technique must be used.

Before adding a substance or medication, verify that it is soluble and/or stable in dextrose and

that the pH range of Dextrose Injection, USP is appropriate.

After addition, check for a possible color change and/or the appearance of precipitates, insoluble

complexes or crystals.

Parenteral drug products should be inspected visually for particulate matter and discoloration

prior to administration whenever solution and container permit.

Do not administer unless solution is clear and the seal is intact.

These admixed injections in VIAFLEX plastic containers are intended for intravenous

administration using sterile equipment.

Use of an in-line filter is recommended during administration of all parenteral solutions where

possible.

Mix thoroughly when additives have been introduced. Do not store solutions containing

additives.

For single use only.

Discard any unused portion.

OVERDOSAGE

Excess administration of Dextrose Injection, USP can cause HYPERglycemia, adverse effects on

water and electrolyte balance, and corresponding complications (see Warnings and Precautions

and Adverse Reactions). For example, severe HYPERglycemia and severe dilutional

hyponatremia, and their complications, can be fatal.

Interventions include discontinuation of Dextrose Injection, USP administration, dose reduction,

administration of insulin and other measures as indicated for the specific clinical constellation.

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Clinically significant overdose of Dextrose Injection, USP may, therefore, constitute a medical

emergency.

DOSAGE FORM, COMPOSITION AND PACKAGING

How Supplied

See Table 1.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due

to moisture absorption during the sterilization process may be observed. This is normal and does

not affect the solution quality or safety. The opacity will diminish gradually. Check for minute

leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be

impaired.

Preparation for Administration

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To Check Compatibility

Additived to be added must be compatible to each other as well as to the products in the

condition of use. Consult pharmacist and/or product labeling of each of the additives for

compatibility. Do not add incompatible additives. After adding an additive into the solution and

thoroughly mixing, further visual inspection of the resultant solution for incompatibility is very

important even if all the additives are theoretically compatible in the condition of use.

To prepare the solution for administration

1. Prepare medication site.

2. Using a syringe and 20 - 22 gauge needle, puncture resealable rubber plug at target area and

inject additive/medication solution into the container. Multiple additions may be made in this

manner until desired amount of additive/medication has been added.

3. Mix the solution and additive/medication thoroughly. For high density medications such as

potassium chloride, squeeze ports while ports are upright and mix thoroughly.

4. Visually inspect the resultant solution. If precipitates, particulate matter, discoloration and/or

other abnormalities appear, discard the solution.

5. If no abnormality is identified in the resultant solution, the solution is ready for administration.

To add medication during the process of solution administration:

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1. Close clamp on the set.

2. Prepare medication site.

3. Using a syringe and 20 - 22 gauge needle, puncture resealable rubber plug at target area and

inject additive/medication solution into the container. Multiple additions may be made in this

manner.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while container is in the upright position.

6. Mix the solution and medication thoroughly.

7. Visually inspect the resultant solution. If precipitates, particulate matter, discoloration and/or

other abnormalities appear, discard the solution.

8. If no abnormality is identified in the resultant solution, return the container to in-use position

and continue administration.

STORAGE

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect

from freezing. It is recommended the product be stored at 15˚ - 25˚C.

Baxter Corporation

Mississauga, ON L5N 0C2

Baxter and Viaflex are trademarks of Baxter International Inc.

Last revised: November 21, 2018

prescribing information - baxter

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